A Timeline Study of Alcohol Use and Its Relationship to Insomnia - Full Text View

Sponsor:	Medical University of South Carolina
Collaborator:	Sunovion
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00580411

Purpose

This study is an epidemiological and descriptive study of the lifetime relationship of insomnia to alcohol problems.

Condition	Phase
Insomnia Alcohol Problem	Phase II

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	A Timeline Study of Alcohol Use and Its Relationship to Insomnia

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Alcoholism

Drug Information available for: Ethanol

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

To characterize the temporal relationship between insomnia and alcohol dependence, alcohol abuse or heavy drinking and determine if this relationship affects the severity of alcohol use. [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the utility of 3 sleep disorder instruments: the ISI, the SDQ-8 & the ESS in an inpatient or outpatient population of subjects reporting insomnia with a lifetime history of alcohol dependence, alcohol abuse or heavy drinking. [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	March 2007
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Alcohol Problem First Alcohol Problem precedes Insomnia
Insomnia First Insomnia Precedes Alcohol Problem

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

We wish to study individuals who meet lifetime criteria for alcohol dependence, abuse or heavy drinking and who self-report current insomnia.

Criteria

Inclusion Criteria:

Subjects must be between the ages of 18-70, may be male or female, and from any ethnic background.
Individuals must have the capacity to give IRB-approved study consent.
Subjects must at least have a lifetime history of being heavy alcohol drinkers (i.e., drinks approximately 21 alcoholic drinks or more per week). Alternatively, subjects are eligible if they meet criteria for a lifetime history of either alcohol dependence or alcohol abuse. Overall, a subject must meet at least one of these alcohol criteria: a lifetime history of heavy drinking, alcohol abuse or alcohol dependence.
Subjects must have a complaint of chronic insomnia, reporting either six or less hours TST, on average at least three times per week.

Exclusion Criteria

Potential subjects with a lifetime diagnosis of Bipolar Affective Disorder, Schizophrenia, Borderline Personality Disorder, dementia of any type, or epilepsy will not be admitted to the study.
Subjects will be excluded with a diagnosis of any other substance dependence syndrome other than alcohol dependence, nicotine dependence, and/or caffeine dependence. However, individuals may have a history of episodic abuse of cannabis, cocaine, sedatives/hypnotics and opiates, amphetamines, and hallucinogens. Also, subjects may be on prescription benzodiazepine or related sedative/hypnotic therapy.
Any condition or treatment of a condition that is likely to confound the experimental design or the results will be prohibited by the PI.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580411

Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

Sunovion

Investigators

Principal Investigator:

Robert Malcolm, MD

Medical University of South Carolina

More Information

No publications provided

Responsible Party:	Robert Malcolm, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00580411 History of Changes
Other Study ID Numbers:	HR#16934, Contract ID ESRC343, DPMCDA
Study First Received:	December 19, 2007
Last Updated:	May 15, 2009
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Alcohol Drinking
Alcoholism
Sleep Initiation and Maintenance Disorders
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders

Nervous System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012